Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo

Launched by ASTRAZENECA · Jul 8, 2025

Keywords

ClinConnect Summary

This study is looking at how well a medicine called Breztri (also known as Trixeo) works for adults with moderate to severe Chronic Obstructive Pulmonary Disease, or COPD. COPD is a lung condition that makes it hard to breathe and can get worse over time, especially after flare-ups called exacerbations. This medicine combines three types of treatments into one inhaler and is recommended for people with more serious symptoms. The study will follow patients for one year to see how the medicine affects their health and quality of life in everyday settings across different countries in Latin America, Asia, and the Middle East & Africa.

Adults between 30 and 79 years old who have had COPD for at least a year and are about to start Breztri treatment may be eligible to join. Participants will need to give their consent and be able to understand and complete questionnaires about their symptoms and well-being. People with certain other lung diseases, recent serious heart or lung problems, or recent hospital stays for COPD flare-ups won’t be able to join. Throughout the study, patients will receive their regular care while researchers observe how the medicine impacts their breathing and daily life, helping to provide real-world information about its benefits and side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following inclusion criteria:
• • 1. Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart.
• • 2. Male or female patients aged over 30 years and under 80 years at the time of enrolment.
• • 3. Patients providing a written Informed Consent\* prior to inclusion to the study.
• • \*Prescription of BGF should be prior to the signed informed consent and the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study.
• • 4. Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.
• Exclusion Criteria:
• Patients who meet any of the following criteria will not be eligible to participate in the study:
• • 1. Patients with COPD due to documented α-1 antitrypsin deficiency.
• • 2. Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism).
• • 3. Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit.
• • 4. Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment.
• • 5. Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women.
• • 6. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases.
• • 7. Patients currently participating in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study or participation in any interventional trial in the last 30 days prior to enrolment.
• • 8. Patients with respiratory tract infection (including COVID-19 infection) ) that has not resolved ≤30 days prior to BGF MDI initiation and those exhibiting persistent long-COVID symptoms are excluded from the study.